CN100335157C - Systems and methods for mixing and transferring flowable materials - Google Patents

Systems and methods for mixing and transferring flowable materials Download PDF

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Publication number
CN100335157C
CN100335157C CN 01818005 CN01818005A CN100335157C CN 100335157 C CN100335157 C CN 100335157C CN 01818005 CN01818005 CN 01818005 CN 01818005 A CN01818005 A CN 01818005A CN 100335157 C CN100335157 C CN 100335157C
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systems
methods
mixing
transferring
flowable
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CN 01818005
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Chinese (zh)
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CN1471426A (en )
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保罗·M·桑德
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科丰公司
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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING, DISPERSING
    • B01F7/00Mixers with rotary stirring devices in fixed receptacles, i.e. movement of the receptacle not being meant to effect the mixing; Kneaders
    • B01F7/00008Stirrers, i.e. rotary stirring devices
    • B01F7/00233Configuration of the rotating mixing element
    • B01F7/00391Helices, i.e. stirrers comprising a helically shaped band; Stirrers composed of helically shaped band sections
    • B01F7/00433Helices, i.e. stirrers comprising a helically shaped band; Stirrers composed of helically shaped band sections ribbon shaped, i.e. with an open space between the helical ribbon flight and the rotating axis
    • B01F7/00441Helices, i.e. stirrers comprising a helically shaped band; Stirrers composed of helically shaped band sections ribbon shaped, i.e. with an open space between the helical ribbon flight and the rotating axis forming open frameworks or cages
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING, DISPERSING
    • B01F13/00Other mixers; Mixing plant, including combinations of mixers, e.g. of dissimilar mixers
    • B01F13/0016Movable or transportable mixing devices or plants
    • B01F13/0018Movable mixing devices, i.e. apt to be shifted or displaced from one place to another, e.g. by human force
    • B01F13/002Movable mixing devices, i.e. apt to be shifted or displaced from one place to another, e.g. by human force portable during use, e.g. hand-held
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING, DISPERSING
    • B01F15/00Accessories for mixers ; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F15/00928General build-up of the mixers
    • B01F15/00941General build-up of the mixers the mixer or mixing elements being collapsible, i.e. when discharging the products
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING, DISPERSING
    • B01F7/00Mixers with rotary stirring devices in fixed receptacles, i.e. movement of the receptacle not being meant to effect the mixing; Kneaders
    • B01F7/00008Stirrers, i.e. rotary stirring devices
    • B01F7/00016Nature of the rotating mixing element
    • B01F7/0005Deformable stirrers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802Equipment for handling bone cement or other fluid fillers
    • A61B17/8805Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • A61B17/8827Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it with filtering, degassing, venting or pressure relief means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00902Material properties transparent or translucent
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B2050/005Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover
    • A61B2050/0066Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover with additional sealing means, e.g. O-ring
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B2050/005Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover
    • A61B2050/0067Types of closures or fasteners
    • A61B2050/0083Snap connection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A61B50/33Trays
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006Properties of materials and coating materials
    • A61F2002/3009Transparent or translucent
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0071Additional features; Implant or prostheses properties not otherwise provided for breakable or frangible
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0091Additional features; Implant or prostheses properties not otherwise provided for transparent or translucent
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING, DISPERSING
    • B01F2215/00Auxiliary or complementary information in relation with mixing
    • B01F2215/0001Field of application of the mixing device
    • B01F2215/0029Mixing ingredients for bone cement

Abstract

提供一种用于混合和传送骨填充材料的装置。 It provided an apparatus for mixing and conveying the bone filler material is provided. 该装置包括用于容纳处于未混合状态的组分的容器。 The apparatus comprises a container for receiving the components in an unmixed state. 提供一种可以插入到该容器中用来混合这些组分的混合元件,还有提供一种具有驱动部件和从动部件的促动器,该促动器可拆卸地连接在混合元件上。 To provide a container which can be inserted into the mixing member for mixing these components, there is provided an actuator having a drive member and a driven member, the actuator is detachably connected to the mixing element.

Description

用于混合和传送可流动材料的系统和方法 Systems and methods for mixing and conveying the flowable material

相关申请本申请要求了于2001年10月25日申请的序列号为No.60/243195的美国临时申请的优先权。 RELATED APPLICATIONS This application claims the serial number 2001 October 25 filed US Provisional Application No.60 / 243195 of priority.

技术领域 FIELD

本发明涉及尤其在医疗领域中用来将多种材料混合在一起并且将这些材料传送进其它器械中的系统和方法。 The present invention relates in particular in the medical field for various materials are mixed together and transmit these materials into the systems and methods in other instruments.

背景技术 Background technique

用于在医疗领域中将多种材料混合在一起例如将由粉末材料构成的聚(甲基丙烯酸甲酯)骨接合剂与一种液态单体混合以用作骨填充材料的现有方法和装置往往会产生不令人满意的结果。 In the medical field for a variety of mixed materials such as poly (methyl methacrylate) bone cement powder with a liquid monomeric material by mixing in a conventional method and apparatus is often used as a bone filler material It will produce unsatisfactory results.

通常,在外科固定中,为此所采用的器具包括用来容纳这些组分的小碗和用于在该碗中混合这些组分的棍子(例如普通的牙舌板)。 Typically, in surgical fixation, used for this purpose include instruments for receiving bowl for mixing these components, and these components of the stick (e.g., tongue conventional dental) in the bowl. 如果采用粉末材料的话,则通常将该材料从其容器直接倒进该碗中。 If the powder material, then typically the material is directly poured into the bowl from its container. 因此,由于粉末材料会溢出,所以该方法往往比较脏。 Accordingly, since the powder material will overflow, this method is often dirty. 在这些组分中的一种是液态单体的情况中,该方法会出现由该液态单体释放出的有害烟雾。 A case where these components are in the liquid monomer, which will be released from the liquid monomer harmful fumes.

在混合这些组分之后,如在骨填充材料的情况中一样,会碰到其它问题。 , As in the case of a bone filling material after mixing the components, we encounter other problems. 当要将该骨填充材料分配进骨头的空腔时,通常的做法是首先将该材料传送进注射器中,然后将该材料传送进该器械以便输送给该空腔。 When the cavity for dispensing the bone filler material into the bone, the usual practice is to first transfer the material into the syringe, the material is then transferred into the device for delivery to the cavity. 通过将完全接合的柱塞穿过注射器本体回撤将该材料抽上来或者通过除去注射器柱塞然后从注射器的后面将该材料倒进并且重新插入柱塞,由此装填该注射器。 The material is pumped retracement fully engaged by the plunger through the syringe body or the material is then poured from the back of the syringe plunger by removing and re-inserting the plunger of the syringe, whereby the syringe filling. 这是一种困难且麻烦的过程。 This is a difficult and cumbersome process. 因此,需要提供一种将同时含有烟雾的材料混合并且容易且干净地将内容物传送或分配进其它器具中。 Accordingly, it is necessary to provide a mixture containing both the material and the smoke easily and cleanly dispensed into the content transmission or other appliance.

发明内容 SUMMARY

虽然医疗产品的各个制造商已经试图开发、制造并且提供各种用于混合和/或分配聚(甲基丙烯酸甲酯)骨接合剂的系统(例如Depuy-参见PCT公开No.WO97/21485,Immedica-参见PCT公开No.WO99/37256以及Stryker-参见美国专利No.6042262),但是这些系统往往昂贵,太复杂,需要外延和/或外部供能附件,或者不能混合少量骨填充材料。 While various manufacturers have been trying to develop a medical product, and provide various manufacturing for mixing and / or distribution of poly (methyl methacrylate) bone cement system (e.g. Depuy- see PCT Publication No.WO97 / 21485, Immedica - see PCT Publication No.WO99 / ​​37256, and U.S. Patent No. Stryker- see No.6042262), but these systems are often costly, too complex, require epitaxial and / or external powered accessory, or a small amount of bone filler material can not be mixed. 因为这些或其它问题,需要对尤其在医疗领域中用来混合和传送材料的系统和方法进行改进。 Because these and other problems, in particular the need for a system and method for mixing and conveying the material improvement in the medical field.

本发明公开了一种方法,包括:提供用于混合和分配骨填充材料的装置,该装置包括容器、分配器出口和底座,该容器具有在外围包围内部的侧壁,该内部用于容纳处于未混合状态下的骨填充材料的组分,该容器包括第一端部区域和与第一端部区域对置隔开的第二端部区域,该分配器出口形成在邻近第二端部区域处的侧壁上,并与容器的内部连通,该底座在第二端部区域上,用来将第一端部区域支撑在竖立状态下,而且该底座的尺寸和结构适于抵抗容器在使用期间的倾倒;提供混合元件,该混合元件的尺寸适于在底座将第一端部区域支撑在竖立状态下的同时通过第一端部区域将混合元件插入容器的内部,用来混合在容器内部的骨填充材料的组分,混合元件的尺寸还适于在组分混合之后通过竖立的第一端部区域从容器的内部撤走混合元件;提供柱塞 The present invention discloses a method, comprising: providing a device for mixing and dispensing a bone filling material, the apparatus comprising a container, a dispenser and a base outlet, the container having a sidewall surrounding the periphery at the inside, in the interior for receiving component of the bone filling material in a state not mixed, the container includes a first end region and a first end region and the opposing second end region spaced, the dispenser outlet is formed adjacent the second end region on the side walls, and communicates with the interior of the container, the base region at the second end, the first end region for supporting an upright position, and the size and structure of the container base adapted to resist using during pouring; providing a mixing element, the mixing element is adapted to the size of the first end region through the mixing element into the interior of the container in the base region of a first end portion supported in an upright state while the interior of the container for mixing the components of bone filler material, the size of the mixing element is further adapted after the components are mixed inside the container withdrawn from the mixing element by a first end region of the upright; providing a plunger 该柱塞的尺寸适于在撤走混合元件之后通过第一端部区域将该柱塞插入容器的内部以通过所述内部向第二端部区域前进,用来在底座将第一端部区域支撑在竖立状态下的同时通过分配器出口分配骨填充材料的混合的组分;把处于未混合状态下的骨填充材料的组分放进所述内部;在底座将第一端部区域支撑在竖立状态下的同时,通过第一端部区域将混合元件插入容器的内部;在底座将第一端部区域支撑在竖立状态下的同时,操纵混合元件以混合在容器内部的骨填充材料的组分;在组分混合之后,在底座将第一端部区域支撑在竖立状态下的同时,通过竖立的第一端部区域从容器的内部撤走混合元件;在从容器的内部撤走混合元件之后,在底座将第一端部区域支撑在竖立状态下的同时,将柱塞插入所述内部;和在底座将第一端部区域支撑在竖立状态下 The size of the plunger is adapted to withdraw the plunger into the container after mixing element through the first end portion to the interior region through the internal forward toward the second end region for the base region of the first end portion while supported in an upright state by the mixed components of the dispenser outlet for dispensing filler bone; bone filling material in the component in the non-mixed state into the interior; in the base region of the support at a first end portion while in the upright state, the first end region of the mixing elements inserted inside the container; the first end portion of the base region of the support in the erected state are simultaneously actuating the mixing element to mix the bone filler material in the interior of the container group points; after the components are mixed in the base region of the first end portion supported in an upright position while the mixing element is withdrawn from the interior of the container through the first end region of the upright; mixing element withdrawn from the interior of the container Thereafter, the base region of the first end portion supported in an upright position while the inner plunger is inserted; and the base region of the first end portion supported in an upright position 同时,使柱塞通过所述内部向第二端部区域前进,用来通过分配器出口分配骨填充材料的混合的组分。 At the same time, advances the plunger toward the second end portion through the internal region, an outlet for dispensing the mixed components through the bone filler material dispenser.

本发明的一个方面在于,提供手持系统以及用于使用这些系统的相关方法,这些系统在混合之前精确地测量出这些组分,在混合期间容纳这些组分,机械地混合或搅拌该骨填充材料,并且方便且干净地将该混合物分配进其它器具中。 One aspect of the invention is to provide a hand-held system, and related methods for using these systems, these systems are accurately measured before mixing these components, these components are housed during the mixing, mechanical mixing or stirring the bone filler material , easily and cleanly and the mixture was dispensed into the other appliance. 该手持系统提供一种用来混合并且传送材料的简单、快速且成本节约的方法。 This provides a simple handheld system for mixing and conveying the material, rapid and cost-saving method.

本发明的另一个方面在于提供手持系统和用于使用这些系统的相关方法,这些系统在混合期间完全容纳着这些组分(理想地消除了在混合期间释放出的有害烟雾的溢出)。 Another aspect of the present invention to provide a hand-held system and related methods for using these systems, these systems are completely accommodated during the mixing of these components (ideally eliminating overflow released during the mixing of harmful fumes).

本发明的一个方面提供一种组件,它包括用于容纳处于未混合状态的例如骨填充材料的组分的容器。 One aspect of the invention provides an assembly comprising a container for ingredients such as accommodating a bone filling material in a non-mixed state. 该组件还包括可以插入进容器中以混合这些组分的混合元件。 The assembly further includes a mixing vessel mixing elements can be inserted into these components. 该组件还包括用于混合元件的促动器,它包括驱动部件和与该驱动部件连接的从动部件。 The assembly further includes an actuator for mixing the components, comprising a drive member and a driven member connected to the drive member. 该促动器可拆卸的连接在混合元件上。 The actuator is removably coupled to the mixing element. 在彻底混合之后,可以将该混合元件拆除和/或将柱塞插进该容器中以传送或分配该混合物。 After thorough mixing, the mixing element can be removed and / or the plunger is inserted into the vessel to transfer or assign the mixture.

在一个实施方案中,混合元件包括随着转动混合这些组分的桨叶。 In one embodiment, the mixing element comprising a blade with rotation of the mixing of the components. 该桨叶可以包括一种用来促进组分混合的结构,例如多个孔。 The blade may include one structure to facilitate mixing of the components, for example, a plurality of holes. 在该布置中,该促动器包括使桨叶转动的驱动部件。 In this arrangement, the actuator comprises a driving member rotating blades. 促动器可以包括传动链例如行星齿轮传动链,该传动链将驱动部件连接在从动部件上。 The actuator may include a drive train such as a planetary gear train, the drive train is connected to the drive member to the driven member. 优选的是,该驱动部件可以手动操纵,从而不需要任何外部能源。 Preferably, the drive means may be manually manipulated such that no external energy.

在一个实施方案中,该容器包括分配阀。 In one embodiment, the container comprising a dispensing valve. 该分配阀在混合步骤期间是关闭的,并且在进行传送或分配步骤时手动操纵以打开和关闭。 The dispensing valve is closed during the mixing step and during the step of transmitting assigned or manually operable to open and close.

附图说明 BRIEF DESCRIPTION

图1A和1B为一成套器具的各个实施方案的平面图,该成套器具包含有体现了本发明特征的用于混合和分配可流动材料的系统的各个组成部件;图2A和2B为形成在图1A和1B中所示系统的一部分的容器的各个实施方案的透视图;图3为形成在图1A中所示系统的一部分的支座的透视图;图4为可以形成在图1A和1B中所示系统的一部分的促动器的侧面透视图;图4A-4F为促动器手柄结构的可选实施方案的侧面透视图;图5A为在图4中所示促动器的底视图;图5B为促动器的可选实施方案的底视图;图6A为在图4中所示促动器的分解透视图;图6B为促动器的可选实施方案的分解透视图;图7为形成在图1A和1B中所示系统的一部分的混合元件的一个实施方案的透视图;图8为形成在图1A和1B中所示系统的一部分的混合元件的另一个实施方案的透视图;图9为形成在图1A和1B中所示系统的一 1A and 1B are plan views of various embodiments of a kit of which comprises a kit of various components reflect a system for mixing and dispensing flowable material features of the invention; FIGS. 2A and 2B are formed in FIG. 1A and a perspective view of the container of the various embodiments of the system shown in part 1B; FIG. 3 is a perspective view of the holder is formed in a portion of the system shown in FIG. 1A; FIG. 4 may be formed in FIGS. 1A and 1B are side perspective view of a portion of the actuator system shown; FIG. 4A-4F is a side perspective view of an alternative embodiment of the actuator handle structure; FIG. 5A is a bottom view of the actuator shown in FIG. 4; FIG. 5B is a bottom view of an alternative embodiment of the actuator; is an exploded perspective view of the actuator shown in FIG. 6A in FIG. 4; FIG. 6B is an exploded perspective view of an alternative embodiment of the actuator; FIG. 7 is a formed in a perspective view of one embodiment of a portion of the mixing element of FIG. 1A and FIG. IB system; FIG. 8 is a perspective view of another embodiment is formed in the mixing element portion of the embodiment of FIG. 1A and FIG. IB system; and FIG. 9 is formed in the system shown in FIG. 1A 1B is a 分的混合元件的另一个实施方案的透视图;图10为插入到在图3中所示支座中的在图2中所示容器的透视图,并且还显示出加入到该容器的部件;图11为插入到在图4中所示促动器的下半部的外侧中的在图8中所示混合元件的近端的透视图;图12为如在图13中的装配视图中所示一样的促动器、混合元件、容器和支座组件的分解视图;图13为在图12中所示的组件的透视图,显示出由一只手抓住并且手动转动的促动器,并且显示出由操作人员的另一只手抓住的容器,所述促动器的转动用来混合在该容器中的材料;图14为在这些材料已经在容器中经过混合之后插入在该容器中的柱塞的透视图;图15为在从容器中分配材料之前从容器中除去的支座的透视图;图16为插入在装有材料的容器中的柱塞的透视图,该材料现在准备进行分配;图17为从容器中分配出的在该容器内 Another embodiment of the mixing element partial perspective view of the embodiment; FIG. 10 is a perspective view of the insert holder shown in FIG. 3 in the vessel shown in Figure 2, and also showing components added to the container; perspective view of the proximal end of the mixing element shown in FIG. 8, FIG. 11 to be inserted into the outer side of the lower half of the actuator shown in FIG. 4; FIG. 12 is a view as in FIG. 13 fitted in the shows an exploded view of the same actuator, the mixing element, the container and the seat assembly; FIG. 13 is a perspective view of the assembly shown in FIG. 12, showing grasped by one hand and manually rotating the actuator, and shows gripped by the other hand of the operator of the container, the actuator is rotated for mixing material in the vessel; FIG. 14 after having been inserted into the mixing vessel of these materials in the container perspective view of the plunger; FIG. 15 is a perspective view of the holder removed from the vessel before dispensing material from the vessel; FIG. 16 is a perspective view of a container containing the material inserted in the plunger, the materials are now ready for dispensing; FIG. 17 of the inner container is dispensed from the container 混合的材料的透视图;图18为形成在图1B中所示系统的一部分的促动器的上半部的底视图;图19为柱塞组件的透视图,显示出用于排气阀的开口;图20为具有用来固定在图2B的容器上的组件的分配阀的一个实施方案的透视图;图21为具有可选安装的真空管道的图2B的容器的透视图;并且图22为图21的容器的局部剖开视图;图23为图21的容器的另一个局部剖开视图;图24A为适用于用在图21的容器中的可折叠混合元件的一个实施方案的透视图;图24B为图24A的可折叠混合元件的侧视图;图25为适用于用在图21的容器中的可折叠混合元件的另一个实施方案的透视图;图26为适用于用在图21的容器中的可折叠混合元件的另一个实施方案的透视图。 A perspective view of a mixed material; FIG. 18 is a bottom view of the upper half is formed in the actuator portion of the system shown in FIG. IB; Fig. 19 is a perspective view of the plunger assembly, showing an exhaust valve for opening; FIG. 20 is a perspective view of one embodiment of a dispensing valve of the container for fixing of the assembly of FIG. 2B; FIG. 21 is a perspective view of a vacuum duct mounted optional container of FIG. 2B; and FIG. 22 It is a partial cut-away view of the container of FIG. 21; FIG. 23 is another partial cut-away view of the container of FIG. 21; FIG. 24A is a perspective view of a suitable embodiment of a collapsible mixing element used in the container of FIG. 21 in FIG. ; FIG. 24B is a collapsible mixing element side view of FIG. 24A; FIG. 25 is a perspective view of another suitable embodiment of the mixing element used in a collapsible container in FIG. 21; FIG. 26 is suitable for use in FIG. 21 a perspective view of another embodiment of a container of a collapsible mixing element.

具体实施方式 detailed description

这些实施方案描述了在混合骨填充材料方面体现了本发明的特征的系统和方法。 These embodiments describe systems and methods embodying features of the invention in terms of mixing bone filler material. 但是,应该理解的是,所述的这些系统和方法并不限于它们在混合骨填充材料上的用途。 However, it should be appreciated that the systems and methods are not limited to their use in the mixing of bone filler material. 这些系统和方法可以适合用在医疗领域内和之外的许多用途中。 These systems and methods may be suitable for use in many applications within and outside the medical field.

还应该理解的是,这里所述的这些发明的各个组成部件可以由非铁的和/或非金属材料构成,这将允许这些各个实施方案能够用在磁性和/或全室MRI环境中。 It should also be appreciated that the various components of the invention described herein may be formed of non-ferrous and / or non-metallic materials, which will allow each of these embodiments can be used in a magnetic and / or whole room MRI environment.

I.组成部件图1A显示出布置成一成套器具200的组成部件,这些部件可以相互结合使用以形成一种材料混合和传送系统。 I. FIG. 1A shows the component parts arranged in a kit of components 200, these components may be used in conjunction with each other to form a material mixing and delivery system. 这些组成部件的数目和结构可以变化。 The number and structure of the component parts may vary. 在图1A中,该成套器具200包括:用于容纳材料的容器12,用来进行混合并且在混合之后用来传送或分配这些材料;支座14,用来容纳该容器12;混合元件16,它可以插入到容器12中以混合这些材料;促动器18,用来驱动混合元件16;柱塞20,它可以插入到容器12中以从容器12中将混合的材料挤压出;分配元件22,用来分配从容器12中挤压出的混合材料;以及测量装置24,用来测量装在用来进行混合的容器12中的材料。 In FIG. 1A, the appliance 200 kit comprising: a container 12 for receiving material to be mixed and used for transmission or distribution of these materials after mixing; support 14, 12 for accommodating the container; mixing elements 16, it can be inserted into the container 12 to mix these materials; actuators 18, 16 for driving the mixing element; a plunger 20, which can be inserted into the container to mix the material 12 from container 12 will be squeezed out; distribution element 22, for dispensing the mixed material is extruded from the container 12; and measuring means 24 for measuring the material contained in the container 12 for mixing.

优选的是,部件12、14、16、18、20、22和24由一种基本上刚性的金属、塑料或陶瓷材料构成。 Preferably, the components 12,14,16,18,20,22 and 24 are made of a substantially rigid metal, plastic or ceramic material. 在一个实施方案中,这些部件12、14、16、20、22和24由聚丙烯构成,而部件18由乙缩醛均聚物(由Dupont公司生产的DELRIN材料)或者一种透明或有颜色尼龙构成。 In one embodiment, the components 12,14,16,20,22 and 24 are made of polypropylene, while the member 18 is made of acetal homopolymer (produced by Dupont DELRIN material), or of a transparent or nylon color configuration. 这些部件材料最好不会由于与骨填充材料接触而受到影响和/或可以通过伽马射线进行消毒。 These components due to contact with the material is preferably not affected bone filler material and / or can be sterilized by gamma rays. 当然,可以采用各种其它可选材料,包括能够抵抗与单体接触而不会在有限时间内显著退化的材料。 Of course, various other optional materials, including contact with the monomer capable of withstanding, without significant degradation of the material within a limited time.

A.容器如在图2A中所示一样,容器12具有近端30和远端32。 A. As the container as shown in FIG. 2A, the container 12 having a proximal end 30 and a distal end 32. 容器12还具有最好从近端30延伸至远端32的内孔37。 The container 12 also has a bore 30 preferably extending from the proximal end 32 to the distal end 37 of. 该远端32带有远侧末端34,通过该末端可以分配材料例如骨填充材料。 The distal end 32 having distal tip 34 may be, for example, dispensing material through the distal bone filler material.

容器12的尺寸设定成在使用的不同阶段单独地容纳混合元件16和柱塞20。 Size of the container 12 and the plunger 16 is set to 20 at different stages of use of the mixing element housed separately. 远侧末端34的内表面其尺寸设定为在使用期间支撑混合元件16的远侧末端62,如将在后面更详细地描述的一样。 The inner surface of the distal tip 34 is sized to support the distal tip 16 of the mixing element 62 during use, as will be described in more detail later in the same. 该近端30在容器12的外表面33上带有一组翼片36,用来使容器与促动器18连接,该促动器又可拆卸地连接在混合元件16的近端56上。 The proximal end 30 with the outer surface 33 of the container 12 on a set of fins 36, for the container 18 is connected to the actuator, the actuator in turn is detachably connected to the proximal end 56 of the mixing element 16. 当将柱塞20插入到容器12中时,如将在后面所述一样,这些翼片36还使得医生能够象注射器一样抓住并且操纵容器12和柱塞20,以便在混合之后分配材料。 When the plunger 20 is inserted into the container 12, as will be described later, these flaps 36 as further enable a physician to grasp and manipulate the syringe as the plunger 20 and the container 12 for dispensing material after mixing.

在一个实施方案中,容器12其体积大约为70立方厘米(70cc)。 In one embodiment, the container 12 is approximately 70 cm3 volume (70cc). 当然,可以根据混合元件16和其它相关部件的尺寸以及所要求混合的填充材料量采用其它尺寸的容器12。 Of course, other sizes may be employed depending upon the size of the container 12 and the mixing element 16 and other related components of the mixed amount of filler required. 其它代表性的尺寸可以包括5、10和20cc的注射器。 Other representative dimensions may comprise a syringe of 5, 10 and 20cc. 该容器12的外表面33最好包括显示出容器12内部体积的刻度尺。 The outer surface 33 of the container 12 preferably includes a display 12 showing the interior volume of the container scale. 优选的是,该刻度尺39在容器12的远侧末端34附近开始。 Preferably, the scale 39 starts near the distal tip 34 of the container 12. 该容器12优选由透明的聚丙烯制成以能够在混合期间和在传送期间在将这些材料装在容器12中时观看到所要混合的材料。 The container 12 is preferably made of a transparent polypropylene to time during the mixing and can be transmitted during these materials contained in the vessel 12 to a desired viewing mixed material.

如在图2B中所示一样,在可选的实施方案中,该容器12在远端32处包括一容器底座35。 As shown in FIG. 2B, as in an alternative embodiment, the container 12 includes a distal end 32 at the base of the container 35. 该容器底座35其形状大体上为半球形并且支撑着该容器12的内孔37。 The base of the container 35 which is substantially hemispherical in shape and is supported within bore 37 of the container 12. 在该容器的内孔37内,在容器底座35处设有中心颈部(未示出),其尺寸设定成能够接受并且牢牢保持着混合元件16的远侧末端62,如在前面针对前面实施方案所述一样。 In the inner bore of the container 37, the container 35 is provided at the base of the central neck portion (not shown), sized to accept and firmly holding the mixing element 16 of the distal tip 62, as previously described for the same as the foregoing embodiments. 该容器底座35最好稳定并且提高了内孔37,而且使得更加容易分配或传送被混合的材料。 The base container 35 is preferably stabilized and improves the hole 37, and makes the material easier to be mixed distributing or conveying. 容器底座35其尺寸设定为提供实心支脚以减小容器12倾倒的可能性。 Container base 35 which is sized to provide a solid foot 12 of the container to reduce the possibility of pouring. 该容器12具有用于分配混合的骨填充材料的出口34B。 The bone filler material container 12 having an outlet for dispensing the mixed 34B.

必要的话,该容器12可以包括有用于标准手术室配套真空软管的真空安装件(vacuum attachment)31(参见图2B),用来抽出在容器12中的烟雾和/或排除该材料中的气体。 If necessary, the vessel 12 may comprise a vacuum mounting member for supporting a standard operating room vacuum hose (vacuum attachment) 31 (see FIG. 2B), in the aerosol container 12 and / or to exclude the material for the gas extraction . 该真空软管还可以通过在容器底座35中的凹口31A来进一步固定。 The vacuum hose may also be further secured in the recess 31A of the base of the container 35 through. 如果还需要的话,则该容器12可以形成用于骨填充材料输送枪的料筒。 Also, if desired, the container 12 for the cartridge may be formed bone filler material delivery gun.

B.支座在图1A中所示的系统中,支座14(参见图3)在混合期间支撑着容器12。 B. In the support system shown in Figure 1A, the carrier 14 (see FIG. 3) supporting the container 12 during mixing. 该支座14具有上侧40和下侧42。 The support 14 has upper side 40 and lower side 42. 上侧40具有中心颈部44,其尺寸设定为能够接受并且牢牢保持着容器12的远端32。 40 has a central upper neck portion 44, which is sized to accept and firmly maintain the distal end 32 of the container 12. 在该颈部44内的中心设有一小腔室,其尺寸设定为能够容纳容器12的远侧末端34。 It is provided with a small chamber in the center of the neck portion 44, which is sized to accommodate a distal end 34 of the container 12. 支座14的下侧42具有平坦表面,该表面使得支座14能够平稳地坐放在一表面例如处理工作台上。 Lower side 42 of the support 14 has a flat surface, such that the abutment surface 14 can be smoothly seated in a surface treatment, for example, a table.

单独的支座14对于在图1B中所示的系统不是绝对必要的,因为该容器底座35直接包含在容器12中。 14 for a single carrier in the system shown in FIG. 1B is not absolutely necessary, because the base of the container 35 directly in the container 12.

C.混合元件该混合元件16可以具有各种结构,并且图7、8和9显示出不同的代表性结构。 C. mixing elements of the mixing element 16 may have various structures, and FIGS. 7, 8 and 9 show different representative structure. 在使用中,该混合元件16在容器12内转动以混合装在该容器中的这些材料。 In use, the mixing element 16 rotates to mix the materials contained in the vessel in the container 12.

在各个所述的结构中,该混合元件16具有上侧50和下侧52。 In the configuration according to each, the mixing element 16 has an upper side 50 and lower side 52. 在这些实施方案中,上侧50和下侧52可以具有用作加强件的向外延伸的中央肋条51以保持混合元件16的完整性。 In these embodiments, the upper 50 and lower side 52 may have a central rib extending outwardly as a reinforcement member 51 to maintain the integrity of the mixing element 16. 该混合元件16还可以包括一个或多个横向肋条53。 The mixing element 16 may further comprise one or more transverse ribs 53.

该混合元件16具有近端56和远端57。 The mixing element 16 having a proximal end 56 and a distal end 57. 远端57最好带有扁平末端62,该末端用来装配进容器12的远侧末端34中。 Preferably the distal end 57 with a flat tip 62, the distal tip end 34 to be fitted into the container 12. 混合元件16的远侧末端62最好混合装在容器12的远侧末端34中的组分。 The distal tip 62 is preferably mixed in the mixing element 16 is mounted at the distal tip 34 of the container 12 in the component. 该远侧末端62还最好用作在容器12的远侧末端34内的支撑表面,用来在混合元件16转动时使它保持在容器12内对中,并且限制混合元件16在容器12内进行左右运动。 The distal tip 62 is also preferably used as the container 34 within the distal tip 12 of the support surface for rotation of the mixing elements 16 when inside of it remains in the vessel 12, and to limit the mixing element 16 in the container 12 for about movement. 该远侧末端62还用来使混合元件16保持与促动器18牢牢接合。 The distal tip 62 for further mixing element 16 and the actuator 18 remains firmly engaged.

必要的话,近端56可以带有实心圆柱形顶端58,但是该近端56可以是适用于安装在促动器18上的各种结构。 If necessary, the proximal end 56 may be provided with a solid cylindrical top 58, but the proximal end 56 may be adapted for mounting on the actuator 18 in various configurations. 如将在下面更详细地描述的一样,该顶端58用来与促动器18连接。 As will be described in more detail below, like, for connecting the tip 58 to the actuator 18. 该顶端58具有一横杆60,该横杆有利于从促动器18将转动力传递给如在图7、8和9中所示的混合元件16。 The tip 58 having a cross bar 60, the bar is passed to facilitate the mixing elements as shown in FIGS. 7, 8, 9, 16 and the actuator 18 from the rotational force. 该横杆60还用来使混合元件16通过搭扣在适当位置处与促动器18的键槽89牢牢接合。 The cross bar 60 is also used to snap through the mixing element 16 firmly engages the keyway at position 18 of the actuator 89. 该顶端58还包括有如在图9中所示一样的脊部59,用来提供额外的强度和稳定性。 The top 58 also includes the like as shown in FIG. 9 ridges 59, used to provide additional strength and stability.

如在图7-9中所示一样,该混合元件16还最好具有一个或多个孔61、63、65、67、68和69。 As shown in Figures 7-9, as the mixing element 16 also preferably has one or more apertures 61,63,65,67,68 and 69. 这些孔61、63、65、67、68和69用来帮助将所选的组分例如粉末材料和液态单体混合在一起。 These holes 61,63,65,67,68 and 69 to help the selected ingredients are mixed together, for example, the powder material and the liquid monomer. 这些孔61、63、65、67、68和69最好足够大以使得一些混合物能够流过该混合元件16,由此使得该混合元件16能够以最小的阻力在容器12内转动并且增强所选混合材料的混合。 These holes 61,63,65,67,68 and 69 is preferably large enough such that some mixtures can flow through the mixing element 16, thereby causing the mixing element 16 can be rotated with minimal resistance inside the container 12 and reinforcing the selected mixing the mixed material. 如果增加这些孔61、63、65、67、68和69的尺寸的话,则对转动的阻力变小。 If the increase in size of the holes 61,63,65,67,68 and 69, then the rotation resistance becomes smaller. 但是,同时还需要该混合元件16在该混合物中进行额外的转动以确保彻底混合。 However, this also requires additional mixing element 16 rotates in the mixture to ensure thorough mixing. 更大的孔使该混合过程更容易进行,而更小的孔可能导致这些组分沿着混合元件16“慢慢向上拱”。 The larger pores mixing process easier, the smaller holes 16 of these components may lead to "slow ride up" along the mixing element. 在这种情况中,必须使混合暂时停止以便使得这些组分能够回落进混合物中。 In this case, mixing must be temporarily stopped so that the components can be dropped into the mixture.

理想的是,该混合元件16的尺寸设定为基本上在容器12的内部上延伸。 Ideally, the mixing element 16 is sized to substantially extend in the interior of the container 12. 这种布置可以有利于粉末和液态组分的混合,因为该混合元件16的转动可以从容器的内壁上将粉末和液态组分刮掉,从而确保这些组分均匀混合。 Such an arrangement may facilitate mixing of the powder and liquid components, since the rotation of the mixing element 16 may be scraped from the inner wall of the container on the powder and liquid components, thereby ensuring uniform mixing of the components. 虽然容器12的侧壁和混合元件16之间的实际物理接触不是绝对必要的,但是在至少一个实施方案中,该混合元件16和容器12的侧壁非常紧密地接近。 While the actual physical contact between the sidewall of the container 12 and mixing element 16 is not absolutely necessary, but in at least one embodiment, the sidewall of the mixing element 16 and the container 12 are very close proximity.

在图8中所示的实施方案中,混合元件16最好具有一系列在混合元件16的近端56附近开始的均匀间隔开的小孔65,至少两个在后面的朝着该混合元件16的远端57延伸的大孔69,以及至少两个在远端57处的大小中等的孔67。 In the embodiment shown in FIG. 8, the mixing element 16 preferably has a series of evenly spaced apertures 16 near the proximal end 56 of the mixing element 65 begins, at least two in the back toward the mixing element 16 the distal end 69 of the large hole 57 extends, and at least two medium-sized holes 57 at the distal end 67. 这个实施方案使得能够更加容易进行混合并且减少了前面所述的混合的“上拱”现象;但是,该实施方案通常需要促动器18进行额外的转动。 This embodiment makes it possible to more easily mixed and reduced as previously described mixed "arch" phenomenon; however, this embodiment typically requires additional actuator 18 is rotated. 在该实施方案中,在骨填充材料的情况中促动器18转动大约5至20转就应该足以确保得到合适的混合物。 In this embodiment, the actuator 18 is pivoted from about 5 to 20 revolutions should be sufficient to ensure proper mixture in the case of a bone filling material.

在图7中所示的实施方案中,该混合元件16具有多个均匀间隔开的孔61,它们与肋条51平行地设置,并且该混合元件16在远端62处还具有至少两个孔63。 In the embodiment shown in FIG. 7, the mixing element 16 having a plurality of uniformly spaced apertures 61, the ribs 51 are arranged in parallel, and the mixing element 16 also has at least two holes 63 at the distal end 62 . 该实施方案需要促动器18转动大约5至10转以混合出一种合适的骨填充材料。 This embodiment requires the actuator 18 is pivoted from about 5 to 10 rpm in a suitable mixing the bone filler material. 虽然该实施方案需要更少的转数,但是与前面所述的实施方案相比,该实施方案需要操作人员为这些转动付出更大的强度。 Although this embodiment requires less number of revolutions, but compared with the previously described embodiments, this embodiment requires the operator to pay for such rotation greater strength. 另外,有时需要在混合过程中停止以使得这些组分能够回落到该混合物中。 In some cases, the mixing process needs to stop so that the components can be dropped into the mixture.

在图9中所示的实施方案中,混合元件16具有两个在混合元件16的近端58附近开始的较大孔68,在后面还有至少两个朝着远端57延伸的大孔69。 In the embodiment shown in FIG. 9, the mixing element 16 has two large holes 16 near the proximal end 58 of the mixing element 68 begins, and there are at least two large holes 69 extending toward the distal end 57 . 该实施方案需要促动器18转动大约15至20转以适当地混合该骨填充材料。 This embodiment requires rotation of the actuator 18 to promote about 15 to 20 rotations to properly mix the bone filler material. 当在彻底混合之后从容器12除去该混合元件16时,如在图9中所示一样的混合元件16的最小表面积只允许在该混合元件16上保留最少量的骨填充材料。 When the mixing member 16 is removed from the container 12 after mixing thoroughly, a minimum surface area as shown in FIG. 9 as mixing element 16 allows to retain only the minimum amount of bone filler material on the mixing element 16.

在其它可选实施方案中,该混合元件16可以包括有任意数量的具有各种尺寸和形状(未示出)的孔。 In other alternative embodiments, the mixing element 16 may include apertures having a variety of sizes and shapes (not shown) of any number.

D.促动器促动器18(参见图4和5A以及5B)驱动着该混合元件16。 D. actuator actuator 18 (see FIGS. 4 and 5A and 5B) which drives the mixing element 16. 理想的是,该促动器18由DELRIN材料或一种透明或有颜色的尼龙形成。 Ideally, the actuator 18 is formed of a transparent material or a DELRIN or colored nylon. 如在图4中所示一样,该促动器18其形状为手掌大小的圆柱形。 As shown in FIG. 4, as the actuator 18 which is cylindrical in shape palm-sized.

该促动器18具有一外表面70,该外表面在必要时可以带有刻痕或带有齿以利于使用者抓握。 The actuator 18 has an outer surface 70, an outer surface which, when necessary, with a notch or toothed to facilitate grasping by a user. 图4A-4P显示出促动器的各种可选手柄设计。 FIGS. 4A-4P show various alternative handle design actuator. 该促动器18具有上半部72和下半部74(还参见图6A和6B),这些适用于以各种方式例如紧固件、粘合剂或搭扣配合连接在一起。 The actuator 18 has an upper half 72 and lower half 74 (see also FIGS. 6A and 6B), which are suitable for a variety of ways such as fasteners, adhesive or snap fit together.

促动器18的上半部72用作驱动部件,而促动器18的下半部74是从动部件。 The upper half of the actuator 72 as a driving member 18, while the lower half 74 of the actuator 18 is a driven member. 上半部72相对于下半部74转动。 The upper half 72 is rotated relative to the lower half 74.

促动器18的上半部72和下半部74都具有内侧76和外侧78。 The actuator 72 and the upper half having a lower half 7418 of the inner 76 and outer 78. 如在图6A中所示一样,上半部72的内侧76包含有一环形齿轮73。 As shown in FIG. 6A, as the inside 76 of the upper half 72 includes a ring gear 73. 下半部74的内侧76包含有与所述环形齿轮73啮合的行星齿轮装置84。 74 comprises the lower half of the inner side 76 of the planetary gear 73 meshes with the ring gear 84 of the apparatus.

行星齿轮装置84包括一太阳齿轮86和一个或多个行星齿轮88。 A planetary gear device 84 includes a sun gear 86 and planet gears 88 or more. 太阳齿轮86通过螺钉95轴向固定在促动器18的下半部74上。 The sun gear 86 is axially secured on the lower half of the actuator 7418 by a screw 95. 该行星齿轮88通过螺钉94固定在固定环92上。 The planet gear 8894 is fixed to the fixed ring 92 by screws. 在一个可选实施方案中,这些行星齿轮88将包括两个齿轮,每个齿轮设置在太阳齿轮86的相对侧面上。 In an alternative embodiment, the planetary gear 88 includes two gears, each gear provided on opposite sides of the sun gear 86.

行星齿轮88的齿与环形齿轮73的齿啮合。 The planetary gear 88 with the teeth of the ring gear 73 engage the teeth. 这些行星齿轮88的齿还与太阳齿轮86啮合。 The planet gears 88 also mesh with the teeth of the sun gear 86. 促动器18的上半部72相对于促动器18的下半部74的转动使环形齿轮73转动。 The upper half 18 of the actuator 72 to rotate relative to the lower half 18 of the actuator 74 of the ring gear 73 rotates. 这又使行星齿轮88在促动器18的固定下半部74内转动。 This in turn rotates the planetary gear 88 in the lower half of the actuator 7418 is fixed. 行星齿轮88的转动又使太阳齿轮86在促动器18的下半部74内转动。 Rotation of the planet gears 88 and sun gear 86 is rotated in the lower half of the actuator of 7,418. 在其中具有三个行星齿轮88的实施方案中,环形齿轮73(即促动器18的上半部72)的单圈转动大约等于太阳齿轮86在促动器18的下半部74内转动四圈。 In the embodiment wherein the embodiment having three planet gears 88, the ring gear 73 (i.e. the actuator 18 of the upper half 72) is approximately equal to the rotation lap of the sun gear 86 is rotated in the four lower half 18 of the actuator 74 ring. 在其中具有两个行星齿轮88的实施方案中,环形齿轮73的单圈转动大约等于太阳齿轮86转动三圈。 In the embodiment having two planetary gears 88, the ring gear 73 is rotated lap is approximately equal to the sun gear 86 is rotated three times.

如在图5A中所示一样,促动器18的下半部74的外侧78具有中央狭缝96,该狭缝容纳着混合元件16的圆柱形顶端58。 As shown in FIG. 5A, as the lower half of the outer side 18 of the actuator 74, 78 having a central slit 96, the slit receiving the tip 58 of the cylindrical mixing element 16. 从太阳齿轮86伸出的轴87(参见图6A)延伸进入该狭缝96。 Shaft 87 (see FIG. 6A) extending from the sun gear 86 extends into the slot 96. 在顶端58上的横杆60装配进位于该轴87上的键槽89中(参见图5A),该轴将混合元件16与太阳齿轮连接在一起。 Bar 60 fitted into the top end 58 positioned in the keyway 89 of the shaft 87 (see FIG. 5A), the shaft 16 is connected with the mixing element and the sun gear. 因此,太阳齿轮86的转动将转动传递给混合元件16。 Thus, rotation of the sun gear 86 transmits the rotation to the mixing element 16.

另外,下半部74的外侧78具有稳定结构98(参见图5A)。 Further, the outer side 78 of the lower half 74 having a stabilizing structure 98 (see FIG. 5A). 该结构98邻接和/或抓住容器12的翼片36以防止容器12在太阳齿轮86将转动传递给混合元件16期间转动。 The abutment structure 98 and / or catch flap 36 of the container 12 to prevent rotation of the container 12 during the rotation of the mixing element 16 is transmitted to the sun gear 86. 该稳定结构98通过紧固件99固定在外侧78的下半部74上。 The stabilizing structure 98 by fasteners 99 fixed on the outside of the lower half of 7478. 必要时,该促动器18可以包括用于标准手术室配套真空软管(未示出)的安装件,用来排出在容器12内的烟雾。 If necessary, the actuator 18 may comprise a standard operating room vacuum hose mounting supporting member (not shown), for discharging the fumes in the container 12.

在一可选实施方案(参见图6B)中,促动器18的上半部72具有容纳进促动器18的内表面71(参见图18)中的整体环形齿轮73。 In an alternative embodiment (see FIG. 6B), the upper half 18 of the actuator 72 has an inner surface 71 (see FIG. 18) of the ring gear 73 integrally accommodated within the actuator 18. 促动器18的下半部74具有与环形齿轮73啮合的行星齿轮装置84。 The lower half 18 of the actuator 74 has a planetary gear meshed with the ring gear 73 of the apparatus 84. 该行星齿轮装置84包括一太阳齿轮86和多个行星齿轮88。 The planetary gear device 84 includes a sun gear a plurality of planetary gears 86 and 88. 理想的是,该行星齿轮装置88包括两个行星齿轮88。 Ideally, the planetary gear device 88 comprises two planetary gears 88. 太阳齿轮86通过轴87轴向固定在促动器18的下半部74上。 The sun gear 8687 is axially fixed on the lower half of the actuator 7418 through the shaft. 轴87在顶部用来与上半部72搭扣配合并且在底部用来容纳混合元件16的顶端58。 At the top of shaft 87 to snap fit to the upper half 72 and a bottom portion 16 for receiving the tip 58 of the mixing element. 轴87的中间部分弄成方形以使太阳齿轮86保持在位并且用来接受由太阳齿轮86所施加的转动力。 The intermediate portion of the shaft 87 is square ended up to the sun gear 86 and held in position for receiving the rotational force from the sun gear 86 is applied.

行星齿轮88通过中空齿轮立柱93安装在促动器18的下半部74上。 The planetary gear 88 via a hollow post 93 mounted on the gear actuator of the lower half of 7418. 固定环92具有保持垂片90,这些垂片装配穿过行星齿轮88的中心孔并且延伸进入中空齿轮立柱93(参见图6B)。 Fixing a holding ring 92 tabs 90, which tabs through the center hole of the planetary gear assembly 88 and extend into the hollow uprights gear 93 (see FIG. 6B). 这些保持垂片90具有小末端,它向下延伸穿过中空齿轮立柱93以使固定环92与促动器18的下半部74牢牢地接合。 These holding tabs 90 having a small end, which extends downwardly through the hollow column 93 so that the fixed gear ring 92 and lower half 18 of the actuator 74 is firmly engaged. 该固定环92还最好具有稳定支脚97,它向下延伸以为该行星齿轮装置84提供强度和稳定性。 The fixing ring 92 also preferably has a stabilizing leg 97, which extends downwardly of the planetary gear device 84 that provides strength and stability.

如在图5B中所示一样,促动器18的下半部74的外侧78具有稳定结构98B,它通常是长方形的以允许容器12插入。 As shown in FIG. 5B, as the lower half of the outer side 18 of the actuator 74, 78 has a stable structure 98B, which is generally rectangular container 12 to permit insertion. 该稳定结构98B的长方形形状防止了容器12在太阳齿轮86将转动施加给与混合元件16连接的轴87的期间转动。 The stabilizing structure 98B prevents the rectangular container 12 is applied to the sun gear 86 will rotate during rotation of the mixing element 16 to give the shaft 87 is connected.

E.柱塞该柱塞20(参见图14和16)装配进容器12的孔道37中。 E. The plunger of the plunger 20 (see FIGS. 14 and 16) fitted into the bore 37 in the container 12. 柱塞20在容器12内的前进令人满意地从容器12中排出空气,并且从容器12中分配出材料。 Advancing the plunger 20 within the container 12 in a satisfactorily exhausting air from the container 12, and the material dispensed from the container 12.

如在图19中所示一样,该柱塞20还可以最好包含一个或多个用于一阀门的开口103,该阀门自动地排空在容器12中位于柱塞20和混合骨填充材料之间的空气。 As shown in FIG. 19, as the plunger 20 may also preferably comprise one or more openings 103 for a valve, the valve is automatically emptied container 12 of the plunger 20 and the mixed bone filler materials air between. 该柱塞20可以包括由各种材料制成的密封件101,这些材料包括但不限于不会由于与混合的骨填充材料接触而受到影响的非刚性材料。 The plunger 20 may include a sealing member 101 made of various materials, including but not limited to these materials without non-rigid material due to contact with bone filler material is affected by the mixing. 在一个实施方案中,该柱塞20可以包括具有小球轴承(未示出)的阀门,该阀门使得空气能够在柱塞20前进穿过容器12时逸出。 In one embodiment, the plunger 20 may include a valve having a ball bearing (not shown) of the valve so that air can be advanced through the vessel 12 to escape the plunger 20. 该球轴承(未示出)可以由密度比骨填充材料更小的塑料材料制成。 The ball bearing (not shown) may be made of bone filler material density than the smaller plastic material. 由于柱塞20接触着粘性骨填充材料,所以该球轴承被迫向上进入关闭位置。 Since the plunger in contact with the viscous bone filler material 20, so that the ball bearings are forced upwards into the closed position. 排空空气使得柱塞20和材料之间形成直接接触,这就改善了材料的分配控制。 Evacuating air direct contact between the plunger 20 and the material, which improves the distribution of the control material.

F.分配元件在图1A中所示的系统中,分配元件22包括一喷嘴100,它用来装配在容器12的远侧末端34上(参见图17)。 F. element distribution in the system shown in FIG. 1A, the dispensing member 22 includes a nozzle 100, which is fitted to the distal tip 34 of the container 12 (see FIG. 17). 在另一个实施方案中,LUER接头(未示出)安装进容器12的远侧末端34中。 In another embodiment, LUER joint (not shown) fitted into the distal tip 34 of the container 12. 在另一个实施方案中,接头(未示出)安装进容器12的远侧末端34中,该接头用来与5cc或10cc注射器的主体配合。 In another embodiment, the linker (not shown) fitted into the distal tip 3412 of the container, the connector body for engagement with a 10cc syringe or 5cc. 在另一个实施方案中,将管道(未示出)安装到容器12的远侧末端34中,该管道用来装配在5cc或10cc注射器主体内。 In another embodiment, the pipe (not shown) mounted to the distal tip 34 of the container 12, for fitment within the conduit or 5cc 10cc syringe body.

在图1B中所示的系统中,分配元件22最好通过夹子121(参见图20)搭扣配合到容器12的远端32上。 In the system shown in FIG. 1B, the dispensing member 22 is preferably the distal end 12 by a snap-fit ​​clip 121 (see FIG. 20) to the container 32. 该分配元件22还可以通过其它装置例如利用粘合剂、焊接或通过其它本领域所公知的装置安装在容器12上。 The dispensing member 22 may also be by other means, for example with an adhesive, by welding or other art known means mounted on the container 12. 该分配元件22最好与容器12的出口34B相配(参见图2B)。 The dispensing member 22 and the outlet container 12 is preferably matched 34B (see FIG. 2B). 旋塞阀(未示出)或其它类型的合适阀门可以设在阀体125内并且具有用于混合材料的出口127。 Stopcock (not shown) or other suitable types of valves may be provided in the valve body 125 and an outlet 127 for the mixed material. 分配元件22可以具有一个或多个位于阀体125的端部处的分配手柄123。 Dispensing element 22 may have one or more dispensing portion located at the handle end 125 of the valve body 123. 如在图20中所示一样,两个分配手柄123可以使得可以用左手或用右手来操作分配元件22。 As shown in FIG. 20, as the handle 123 may be such that two distribution can be operated with the right hand or the left hand distribution member 22. 最好将LUER接头129安装到阀体125上以利于安装注射器或带螺纹的骨填充装置。 The adapter 129 is preferably mounted to LUER bone filler device to facilitate mounting the syringe on the body 125 or threaded. 当然,可以根据容纳被传送的混合材料的器具类型将任意数量的其它类型接头或管道安装到阀体125上。 Of course, depending on the type of appliance receiving the mixed material is transferred to any number of other types of joints or pipe 125 is mounted to the valve body.

G.测量装置测量装置24(参见图1A)用来在将这些组分放进用于进行混合的容器中之前测量这些组分。 G. measuring means for measuring means 24 (see FIG. 1A) will be used for these components into the mixing vessel prior to the measurement of these components. 该测量装置24可以具有固定的尺寸,例如10cc量杯,可以是有刻度的,和/或可以包括用于在混合之前筛选颗粒的筛子。 The measuring device 24 may have a fixed size, e.g. 10cc cup, there may be a scale, and / or may comprise a screen for screening of particles prior to mixing.

H.漏斗漏斗10用来帮助将所要混合的这些组分装进或倒进容器12中(参见图1B)。 H. funnel hopper 10 to help put into these components will be mixed or poured into the container 12 (see FIG. 1B).

II.该系统的说明性使用在图1A中所示的实施方案中,将容器12、支座14、混合元件16、促动器18、柱塞20、分配器22和测量装置24以及所要混合的组分聚集在一起以便使用,或者在需要时从成套器具200中抽出。 II. Illustrative of the system used in the embodiment shown in FIG. 1A, the container 12, support 14, the mixing element 16, the actuator 18, plunger 20, and the dispenser 22 and the measuring device 24 to be mixed components for use together, if necessary or kit 200 withdrawn from the appliance. 医生或助手将容器12的远端32插入进支座14的上侧40的颈部44中(参见图10)。 Physician or an assistant to the distal end 12 of the container 32 is inserted into the upper side of the neck portion 44 of support 14 40 (see FIG. 10). 优选的是,将容器12的远侧末端34保持在位于支座14的上侧40上的小腔室46内,从而令人满意地密封被封闭的远侧末端34。 Preferably, the distal tip 12 of the container 34 is held in the small chamber is located on the upper side 14 of the support 40 on 46, so that a satisfactory sealing distal tip 34 is closed.

如图10所示,医生可以使用测量装置24来测量所要混合的组分例如用于聚(甲基丙烯酸甲酯)骨接合剂的粉末组分。 10, the physician can use the components to be mixed is measured by measuring means 24, for example, for poly (methyl methacrylate) bone cement powder component. 将该粉末组分倒进容器12中。 The powder was poured into the vessel 12 component. 如果容器12在其外表面33上带有刻度尺39的话,则可以将该组分加入到该容器12中直到达到所要求的刻度。 If the container 12 with the scale 39, then on the outer surface 33, the components may be added to the graduated vessel 12 until required. 在将粉末组分加入到容器12中之后,加入另一种组分例如用于骨接合剂的液态单体。 After the powder component was added to the container 12, the addition of another component, such as a liquid monomer bone cement used.

然后取出混合元件16和促动器18。 Then remove the mixing element 16 and the actuator 18. 理想的是,已经将混合元件16的近端56插入到位于促动器18的下半部74的外侧78上的狭缝96中(如图11所示)。 Ideally, the mixing element 16 has a proximal end 56 is inserted into the lower half of the actuator 18 located on the outer side of the slit 96 in 7874 (Figure 11). 现在将该组件翻转,并且将混合元件16的远端57插入到容器12的近端30中(在图12的分解视图中所示)。 The assembly is now turned over, and the distal end 57 of the mixing element 16 is inserted into the proximal end 30 of the container 12 (as shown in the exploded view of FIG. 12). 理想的是,该混合元件16如此插入,从而该混合元件16的远侧末端62延伸进入容器12的远侧末端34。 Ideally, the mixing element 16 so inserted, so that the distal tip 62 of the mixing element 16 extends into the distal end 34 of the container 12. 促动器18最好与位于容器12的近端30上的翼片36接合,从而该促动器18的下半部74相对于容器12保持固定不动。 Preferably the actuator 18 engages the tab 30 positioned on the proximal end 36 of the container 12, so that the lower half of the actuator 7418 with respect to the container 12 remains stationary.

医生现在用一只手抓住促动器18的上半部72,同时用另一只手握住支座14、容器12或支座14和容器12(参见图13)。 Now the doctor with one hand grasp the upper half 18 of the actuator 72, while with the other hand holding the holder 14, support 14 and the container 12 or container 12 (see FIG. 13). 然后使促动器18的上半部72相对于容器12来回转动例如半圈,首先顺时针然后逆时针(反之亦然)。 Then the actuator 72 with the upper half 18 of the container 12 is rotated back and forth, for example half a turn, first clockwise and then counterclockwise (or vice versa). 或者,与这个来回运动结合,可以使促动器18沿着单一方向转动。 Alternatively, in conjunction with the movement back and forth, the actuator 18 can be rotated in a single direction. 理想的是,使促动器18转动足够次数以使该混合物充分混合。 Ideally, the actuator 18 is rotated a sufficient number of times so that the mixture thoroughly mixed.

在该混合物被充分混合之后,从容器12中将促动器18和混合元件16拆除并且将它们放在一边。 After this mixture is thoroughly mixed, the container is removed from the actuator 18 and in the mixing element 16 12 and set them aside. 必要时,混合元件16可以在容器12的顶部上刮擦以除去附着在该元件16上的混合物,从而使这混合物返回容器12。 If necessary, the mixing element 16 may scrape on the top container 12 to remove the mixture adhered on the element 16 so that this mixture was returned to the vessel 12. 接着,将柱塞20插入到容器12的近端30中(参见图14)。 Subsequently, the plunger 20 is inserted into the proximal end 12 of the container 30 (see FIG. 14). 现在可以将该组件安全地倒转,并且从容器12中除去支座14(参见图15)。 Now safe to reverse the assembly, and removing the support 14 (see FIG. 15) from the container 12. 优选的是,在插入柱塞20并且使该组件倒转的步骤之前不会从容器12中将支座14拆除。 Preferably, the carrier 14 will not be removed from the container 12 will be inserted prior to the step of the assembly the plunger 20 and the inverted. 在这种情况中,如在骨填充混合物的情况中一样,该混合物可以很容易从在容器12的远侧末端34中的开口流出。 In this case, as in the case of filling a bone mixture, the mixture can easily flow out from the opening at the distal tip 34 of the container 12.

在从容器12中将支座14拆除之后,可以通过使以从注射器中排出空气的通常方式柱塞20前进来从容器12的远侧末端34中排出空气。 After removal from the support 14 in the container 12 can be discharged in the usual manner by allowing air from the syringe plunger 20 forward to expel air from the distal tip 34 of the container 12. 可以通过使柱塞20前进来从容器12中直接分配出该混合物。 The mixture can be dispensed by advancing the plunger 20 from the container 12 directly. 必要时,将分配器22装配到容器12的远侧末端34上。 If necessary, the dispenser 22 is fitted to the distal end 34 of the container 12. 在一个实施方案中,如果分配器22是一喷嘴100的话,则通过喷嘴100来分配该混合物。 In one embodiment, if the dispenser 22 is a nozzle 100, then, the mixture was allocated through the nozzle 100. 在另一个实施方案中,如果该容器12的远侧末端34安装有LUER接头的话,则如在美国专利No.6241734(该专利在这里被引用作为参考)中所披露的一样该LUER接头可以与骨填充装置配合。 In another embodiment, if the distal tip 34 of the container 12 is mounted LUER linker, then as in U.S. Patent No.6241734 (patent which is incorporated by reference herein) as disclosed in the linker LUER mating means can be filled with bone. 当将该LUER接头安装进容器12的远侧末端34中时,该组合使得能够直接填充多个骨填充装置。 When the connector is mounted LUER distal tip 12 into the container 34, so that the composition can be directly filled with a plurality of bone filler device. 在另一个实施方案中,如果容器12的远侧末端34安装有与5cc或10cc注射器的注射器主体配合的接头的话,则可以用容器12中的混合物填充该注射器。 In another embodiment, if the distal tip 12 of the container 34 is attached to the syringe body or 5cc syringe with 10cc of the joint, then the syringe may be filled with the mixture in the container 12. 在另一个实施方案中,容器12的远侧末端34可以安装有装配在5cc或10cc注射器主体内的管道,因此使得该注射器能够从柱塞末端往回填充。 In another embodiment, the distal tip 12 of the container 34 may be mounted in the pipe fitting 5cc or 10cc syringe body, so that the syringe can be filled from the back end of the plunger. 在这个实施方案中,管道插入穿过注射器的柱塞开口。 In this embodiment, the plunger of the syringe is inserted through the conduit opening. 该注射器从其远侧末端向其近端被填充,并且在该注射器填充至所要求的刻度时撤走该管道。 The syringe is filled from its proximal end of the distal tip, and filled to the mark during the withdrawal of the duct in the desired syringe.

在图1B中所示的系统包括用来更便于使用和减少操作步骤的附加特征。 In the system shown in FIG 1B includes additional features for easier use and reduce operation steps. 容器12包装在成套器具200中,分配元件22处于封闭位置。 Container 12 packaged in a kit of 200, dispensing member 22 in the closed position. 在从成套器具200汇集了系统部件(容器12、混合元件16、促动器18、柱塞20以及漏斗10)以及要被混合的材料之后,医生或助手将漏斗10定位在容器12的远端30,并将粉末状的成分倾倒在容器12中。 After collection from the kit of parts of the system 200 (the container 12, the mixing element 16, the actuator 18, the plunger 20 and the hopper 10) and the material to be mixed, physician assistant, or the funnel 10 is positioned at the distal end 12 of the container 30, and the powder is poured into the vessel 12 component. 如果需要,可以在加入液态单体之前向容器12中加入另外的粉末状材料,例如无菌硫酸钡(以使得混合物不透辐射)或抗生素(以防止感染)。 If desired, additional powdered material into the container 12 prior to addition of liquid monomer, for example, sterile barium sulfate (a mixture of such radiopaque) or an antibiotic (to prevent infection). 该混合元件16和促动器18如前面所述一样连接在一起并且被插入到容器12中。 The mixing element 16 and the actuator 18 as previously described as connected together and inserted into the container 12. 促动器18设置成与位于容器12的近端30上的翼片36接合。 The actuator 18 is provided to engage the flap 30 located on the proximal end 36 of the container 12. 医生或助手现在使促动器18转动以如前面所述一样混合该材料。 Physician or assistant now rotates the actuator 18 as described hereinbefore to mixing of the material. 优选的是,可以通过真空软管附件31从容器12中排出在容器12中的单体烟雾。 Preferably, the aerosol can 31 is discharged in the monomer container 12 from the container 12 through the vacuum hose attachment. 在该混合物被充分混合之后,从容器12中将促动器18和混合元件16拆除并且放在一边。 After this mixture is thoroughly mixed, the container is removed from the actuator 18 and the mixing element 16 12 and will set aside. 接着,将柱塞20插入到容器12的近端30中。 Subsequently, the plunger 20 is inserted into the proximal end 30 of the container 12. 可以通过柱塞20中的开口103从该系统中自动地排出空气。 Air can be discharged from the system automatically through the opening 103 in the plunger 20. 然后通过真空软管附件31从容器12的内孔37中排出残余气体/单体混合物,从而进一步减小医生或助手受到的单体烟雾。 Residue gas 31 is then discharged / monomer mixture from the bore 37 of the container 12 through the vacuum hose attachment, thereby further reducing the physician or an assistant by a monomer of smoke. 现在准备传送该混合物。 The mixture is now ready to transfer. 理想的是,如在美国专利No.6241734中所披露的一样直接将混合材料传送给骨填充装置。 Ideally, as in U.S. Patent No.6241734 as disclosed in transferring mixed material directly to the bone filler device. 该步骤省略了将该材料传送给另一个装置例如注射器的必要,该注射器用来填充美国专利No.6241734的装置。 This step is necessary to transfer the material omitted to another device, such as a syringe, the syringe means for filling U.S. Patent No.6241734. 可以通过在柱塞20上向下推压来通过打开的分配元件22直接分配该混合物。 The mixture may be directly dispensed by pushing down on the plunger 20 to the opening 22 through the dispensing member. 或者,可以通过使分配手柄123转动以打开和关闭旋塞阀(未示出)来控制该混合物的流动。 Alternatively, it is possible to control the flow of the mixture by the dispensing handle 123 is rotated to open and close the stopcock (not shown).

如果需要额外的骨填充材料混合物,或者在初始的混合物已经硬化和/或没有用之后需要额外的骨填充材料的话,则可以从促动器18中除去用过的混合元件16(在其上具有骨填充材料)并且用新的混合元件16来替换,从而使得该促动器18可以用来混合额外批量的骨填充材料。 If additional material mixture filling bone, or has hardened and / or no need for additional bone filler material followed by an initial mixture, then can (having from 18 to remove the spent actuator mixing element 16 thereon bone filler material) 16 and replaced with a new mixing element such that the actuator 18 can be used to additional bone filler material mixed batch. 在这种情况中,成套器具200可以包括单个促动器18和测量装置24,并且具有多个容器12、支座14、混合元件16、柱塞20和分配元件22以使得能够混合多批骨填充材料。 In this case, The kit 200 may include a single actuator 18 and the measuring device 24, and having a plurality of containers 12, the carrier 14, the mixing element 16, the plunger 20 and dispensing member 22 so that the bone can be mixed batches Filler.

III.封闭的接合剂混合和传送系统在从医疗材料中释放烟雾和/或蒸汽由于一些原因是不受欢迎的情况中,最好采用一种封闭的混合和传送系统以便制备和/或输送医疗材料例如骨接合剂。 III. Closed cement mixing and delivery system release smoke and / or steam from the medical material is the case for some reason undesirable, it is preferable to prepare and / or use a closed mixing and delivery system or medical delivery material such as bone cement. 例如,来自PMMA骨接合剂的液态单体组分的烟雾和/或蒸汽可以具有非常难闻的气味,并且吸入这些烟雾可能对各个手术室人员以及病人带来显著的健康危险。 For example, smoke and / or steam from a liquid monomer component of the PMMA bone cement may have a very unpleasant odor, and the smoke inhalation may cause significant health risk to the individual patient and operating room personnel.

在由PMMA粉末和液态单体组分构成的骨接合剂的情况中,液态单体在使用之前通常被密封在玻璃罐或安瓿内,而粉末装在塑料袋中。 In the case of bone powder consisting of PMMA cement and the liquid monomer component, the liquid monomer prior to use typically sealed in glass jars or ampoules, and the powder in plastic bags. 这种包装的一个实施例是在市场上可以从Howmedica公司买到的SimplexpPMMA骨接合剂。 One embodiment of such a package is commercially available from Howmedica Company SimplexpPMMA bone cement. 虽然这种骨接合剂的粉末组分通常是惰性的且不容易飘在空中(除非受到充分地搅动),液态单体组分具有非常低的蒸汽压力并且与空气接触时很容易蒸发。 Although the powder component bone cement which is generally inert and does not readily float (except by sufficiently agitated), the liquid monomer component having a very low vapor pressure and contact with air is easy to evaporate in the air.

一旦打开了装有液态单体的玻璃安瓿(通常通过破坏在该玻璃安瓿上的易碎盖子),则该液态单体暴露在大气中并且立即开始蒸发。 Once opened the glass ampoule containing the liquid monomer (typically by breaking on the glass cover frangible ampoule), the liquid monomer is exposed to the atmosphere and immediately begins to evaporate. 而且,在混合过程中,该液态单体继续从液体/粉末混合物中蒸发并排出气体。 Further, during mixing, the liquid monomer and continued evaporating liquid is discharged from a gas / powder mixture. 一旦完成混合,单体继续从液体/粉末混合物中排出气体,直到将该混合物装在封闭的环境内(例如注射器或其它封闭的分配装置或者当将该混合物安放在病人的身体内)。 Upon completion of mixing, the monomer continues to drain the liquid from the gas / powder mixture until the mixture contained within the closed environment (e.g. a syringe or other dispensing means closed or when the mixture is placed in the patient's body). 除非在基本上所有混合和输送操作的步骤期间将该混合物装在封闭的环境中,否则在骨接合剂的混合和分配期间会向手术室释放出大量蒸发的单体。 Unless substantially during the step of mixing and delivery operations of all the mixture is contained in a closed environment, an operating room or the release of substantial evaporation of monomer during bone cement mixing and dispensing.

图22和23描绘了一种接合剂混合和传送系统的可选实施方案,该系统减少了向手术室环境释放蒸发单体。 22 and 23 depict an alternative embodiment of a cement mixing and delivery system, the system reduces the release of the operating room environment monomer evaporation. 在该实施方案中,该容器12包括一单体分配体400。 In this embodiment, the dispensing container 12 comprises a single body 400. 该单体分配体400包括固定夹405、套管410、阻断元件415、盖子420、供料管腔425以及通气管腔430。 The monomer partitioning member 400 includes a retaining clip 405, sleeve 410, blocking member 415, the cover 420, the feeding lumen 425 and vent lumen 430. 优选的是,该分配体固定在容器12上,并且供料管腔425和通气管腔430通过在容器壁中的一个或多个开口(未示出)与容器12的内部连通。 Preferably, the dispensing member is fixed to the container 12, and the feeding lumen 425 and vent lumen 430 through the container wall or a plurality of openings (not shown) in communication with the interior of container 12. 分配体400可以采用各种方式例如通过夹子、粘合剂、焊接或通过本领域所公知的其它方法固定在容器上。 400 may be allocated in various ways, for example, an adhesive, welding, or by other methods known in the art is fixed to the container by a clip.

如在图23中所示一样,固定密封件448最好以气密的方式接合容器12的上开口,从而令人满意地使该容器12与手术室环境隔绝。 As shown in FIG. 23, as the seal member 448 is preferably fixed in an airtight manner on the container engaging opening 12, so that the container 12 is satisfactorily operating room isolated from the environment. 最好在固定密封件448下面并且在容器12的内部设置一滑动密封件450。 And it is preferably a sliding seal 450 disposed in the interior of the container 12 below the fixed seal member 448. 这些密封件448和450可以由各种已知的密封材料例如胶乳橡胶构成。 These seals 448 and 450 may be formed of latex rubber, for example, a variety of known sealing materials. 优选的是,这些密封件448能够在使容器内容物和大气之间保持基本上气密的密封同时允许混合元件16和轴87转动。 Preferably, these seals 448 can be maintained substantially air tight seal while allowing the mixing element 16 and the shaft 87 is rotatable between the container contents and the atmosphere. 另外,该滑动密封件450最好可以在容器12内纵向地移动。 Further, the sliding seal member 450 is preferably longitudinally movable within the container 12. 必要时,该滑动密封件可以包括一内部狭缝或开口(未示出),它使得滑动密封件450能够沿着混合元件16的中心轴线滑动同时与混合元件16保持基本上气密密封。 If necessary, the sliding member may comprise an inner sealing slit or opening (not shown), so that the sliding seal 450 which slidably while maintaining a substantially airtight seal with the mixing element 16 along the central axis of the mixing element 16.

为了制备骨接合剂混合物,将测定量的粉末PMMA组分装进容器12中。 For the preparation of bone cement mixture, a measured amount of powder is put into the vessel 12 component of PMMA. 然后将混合元件和促动器安装在容器上,并且密封件448和450密封接合着该容器12。 Then mixing element and the actuator is mounted on the container, and the sealing member 448 and 450 in sealing engagement with the container 12. 将装有液态单体的密封玻璃安瓿435插入到套管410中。 The sealed glass ampule containing a liquid monomer 435 is inserted into the sleeve 410. 将盖子420安装在套管410上,从而密封该封闭的套管。 The cover 420 is mounted on the sleeve 410, thereby sealing the closure sleeve.

然后,将盖子420拧到安瓿435上,从而将安瓿435挤压在阻断元件415上并且使该安瓿435破裂。 Then, the lid 420 is screwed onto the ampoule 435, thereby pressing the ampoule 435 and 415 in the blocking member 435 such that the ampule breakage. 这样液态单体将会流进套管中,穿过供料管腔425并且与在容器12内的粉末组分接触。 Such liquid monomer will flow into the casing, the feed through the lumen 425 and in contact with the powder components in the container 12. 通气管腔425将缓解任意会在套管中形成的真空。 The vent lumen 425 will relieve any vacuum formed in the sleeve.

现在以前面所述的方式混合该液体和粉末组分。 Now the manner previously described to mix the liquid and powder components. 一旦混合结束,可以通过在促动器18和固定密封件448中的开口(未示出)插入柱塞460,由此可以使滑动密封件450在容器12内朝着混合物前进。 Once the end of the mixing, through an opening (not shown) inserted into the plunger 460 in the actuator 448 and the fixed seal member 18, thereby allowing the sliding seal member 450 moving in the mixture in the vessel 12. 必要时,该滑动密封件450可以包括一迷宫式密封件或其它使得空气能够流过该密封件的装置。 If necessary, the sliding seal 450 may include a labyrinth seal or other seal means such that the air can flow. 优选的是,流过滑动密封件450的任意气体和/或蒸发单体将由固定密封件448拦截。 Preferably, the flow of gas through the sliding seal member 450 of any and / or interceptor 448 is fixed by monomer evaporation seal. 一旦与PMMA混合物接触,则该滑动密封件450将挤压该混合物,然后该混合物可以以前面所述的方式分配。 Upon contact with a mixture of PMMA, the sliding seal 450 will extruding the mixture, and the mixture may be dispensed in a manner previously described.

通过该实施方案,可以从混合和分配系统中分配出PMMA混合物,且不会明显释放出单体烟雾。 By this embodiment, it can be dispensed from the mixing and dispensing system out of a mixture of PMMA, and the monomer does not significantly release the smoke. 一旦分配结束,则可以安全地扔掉整个封闭系统。 Once the dispensing end, you can throw away the entire closed system safely.

图24A、24B、25和26描述了与前面所述的封闭混合和传送系统结合使用的混合元件的各个实施方案。 FIG. 24A, 24B, 25 and 26 describe various embodiments of the previously closed mixing and delivery system associated mixing element used. 这些混合元件尤其适用于在已经完成混合之后拆掉和/或折叠以利于滑动密封件450前进和PMMA混合物分配。 These elements particularly suitable for mixing removed and / or folded to facilitate dispensing the mixture 450 proceeds and PMMA sliding seal after the mixing has been completed. 更具体地说,图24A和24B是由一系列部分460构成的混合元件的视图,这些部分随着混合元件的转动而使这些PMMA组分混合,但是当受到挤压时,它们会以可折叠的方式折叠以使得密封件450能够前进并且能够分配出PMMA混合物。 More specifically, FIGS. 24A and 24B are views of the mixing element portion 460 constituted by a series of mixing these portions with the rotation of the mixing element PMMA these components, but when squeezed, they foldably folded in a manner such that the seal member 450 can be advanced and is capable of dispensing a mixture of PMMA. 图25描绘出一种由螺旋部分构成的混合元件16,该螺旋部分随着混合元件16的转动使PMMA组分混合,但是当受到挤压时会以类似弹簧的方式压缩以使得滑动密封件450能够前进并且能够分配该PMMA混合物。 Figure 25 depicts the mixing element constructed by a helical portion 16, with rotation of the spiral portion 16 of the mixing element to mix the components PMMA, but when squeezed will compress a spring-like manner so that the sliding seal 450 PMMA can advance and the mixture can be allocated. 图26描绘了一种由多个螺旋部分构成的混合元件16,这些部分以类似的方式操作。 26 depicts the mixing element 16 constructed by a plurality of helical portions that operate in a similar manner.

Claims (1)

  1. 1.一种方法,包括:提供用于混合和分配骨填充材料的装置,该装置包括容器、分配器出口和底座,该容器具有在外围包围内部的侧壁,该内部用于容纳处于未混合状态下的骨填充材料的组分,该容器包括第一端部区域和与第一端部区域对置隔开的第二端部区域,该分配器出口形成在邻近第二端部区域处的侧壁上,并与容器的内部连通,该底座在第二端部区域上,用来将第一端部区域支撑在竖立状态下,而且该底座的尺寸和结构适于抵抗容器在使用期间的倾倒;提供混合元件,该混合元件的尺寸适于在底座将第一端部区域支撑在竖立状态下的同时通过第一端部区域将混合元件插入容器的内部,用来混合在容器内部的骨填充材料的组分,混合元件的尺寸还适于在组分混合之后通过竖立的第一端部区域从容器的内部撤走混合元件;提供柱塞,该柱塞的 1. A method, comprising: providing a device for mixing and dispensing a bone filling material, the apparatus comprising a container, a dispenser and a base outlet, the container having a sidewall surrounding the periphery at the inside, in the interior for receiving unmixed component of the bone filling material in a state where the container comprises a first end region and a first end region and the opposing second end region spaced, the dispenser outlet is formed at the area adjacent to the second end of the on the side wall and communicating with the interior of the container, the base region at the second end, the first end region for supporting an upright position, and the size and structure of the base of the container adapted to resist during use pouring; providing a mixing element, the mixing element is adapted to the size of the internal mixing elements inserted into the container through the first end region of the base region of the first end portion supported in an upright state while the interior of the container for mixing the bone components of the filler material, the size of the mixing element is further adapted to withdraw from the interior of the mixing element in the container after mixing the components by a first upstanding end region; providing a plunger, the plunger 寸适于在撤走混合元件之后通过第一端部区域将该柱塞插入容器的内部以通过所述内部向第二端部区域前进,用来在底座将第一端部区域支撑在竖立状态下的同时通过分配器出口分配骨填充材料的混合的组分;把处于未混合状态下的骨填充材料的组分放进所述内部;在底座将第一端部区域支撑在竖立状态下的同时,通过第一端部区域将混合元件插入容器的内部;在底座将第一端部区域支撑在竖立状态下的同时,操纵混合元件以混合在容器内部的骨填充材料的组分;在组分混合之后,在底座将第一端部区域支撑在竖立状态下的同时,通过竖立的第一端部区域从容器的内部撤走混合元件;在从容器的内部撤走混合元件之后,在底座将第一端部区域支撑在竖立状态下的同时,将柱塞插入所述内部;和在底座将第一端部区域支撑在竖立状态下的同时,使柱 After withdrawal inch adapted mixing element through the inside region of the first end portion of the plunger is inserted into the container through the interior of the forward end portion toward the second region for the base region of the first end portion is supported in an upright state simultaneous dispensing through the dispenser outlet bone filler mixed components; the component in the bone filling material in the unmixed state into said interior; the base region of the first end portion supported in an upright position Meanwhile, the first end region of the mixing element into the interior of the container; the first end portion of the base region of the support in an upright position while actuating the mixing element to mix the ingredients of the bone filling material inside the container; in group after mixed well, the base region of the first end portion while supporting the erected state, the mixing element withdrawal from inside the container through the first standing end region; after the withdrawal from the interior of the container mixing elements, the base while the first end region is supported in an upright position, the plunger is inserted into the interior; and the base region of the first end portion supported in an upright position while the column 塞通过所述内部向第二端部区域前进,用来通过分配器出口分配骨填充材料的混合的组分。 Proceeds to the second end portion of the plug through the internal region, for mixing the components of the bone filling material dispensed through the dispenser outlet.
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KR20080081375A (en) 2008-09-09 application
JP2008100091A (en) 2008-05-01 application
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CN1471426A (en) 2004-01-28 application
US20060187747A1 (en) 2006-08-24 application
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US20070121422A1 (en) 2007-05-31 application
JP2004512110A (en) 2004-04-22 application
US7160020B2 (en) 2007-01-09 grant
JP4173991B2 (en) 2008-10-29 grant
WO2002034378A2 (en) 2002-05-02 application
US7278778B2 (en) 2007-10-09 grant
US20080033447A1 (en) 2008-02-07 application
WO2002034378A3 (en) 2002-10-10 application
US20020191487A1 (en) 2002-12-19 application

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